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CTRI Number  CTRI/2025/11/097855 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 17/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Linking What We See on the Skin to What Happens Under the Microscope in Lichen Planus 
Scientific Title of Study   Clinical , Histopathological and Immunohistochemical Correlation of Severity in Lichen Planus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ronita Lenny  
Designation  Post graduate  
Affiliation  Father Muller medical college  
Address  Department of Dermatology , Venereology and Leprosy Fr muller roads , Kankanady ,Mangalore Dakshina Kannada , KARNATAKA ,575002, INDIA

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9606246683  
Fax    
Email  ronitalenny018@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Bhat  
Designation  Professor  
Affiliation  Father mullermedical college  
Address  Department of Dermatology , Venereology and Leprosy Fr muller roads , Kankanady ,Mangalore Dakshina Kannada , KARNATAKA ,575002, INDIA

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845084224  
Fax    
Email  rameshderma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nisha marla  
Designation  Professor  
Affiliation  Father mullermedical college  
Address  Department of Dermatology , Venereology and Leprosy Fr muller roads , Kankanady ,Mangalore Dakshina Kannada , KARNATAKA ,575002, INDIA

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9481148975  
Fax    
Email  nishajmarla@fathermuller.in  
 
Source of Monetary or Material Support  
FATHER MULLER RESEARCH CENTRE Indoor Stadium complex , Father Muller Campus , Kankanady , Mangalore -575 002 , Karnataka ,INDIA  
 
Primary Sponsor  
Name  FATHER MULLER RESEARCH CENTRE  
Address  FR MULLER ROAD KANKANADY MANGALORE 575002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR RONITA LENNY   Father muller medical college   Department of dermatology venereology and leprosy Father muller medical college Father muller road , Kankanady Mangalore 575002
Dakshina Kannada
KARNATAKA 		 9606246683

ronitalenny018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L433||Subacute (active) lichen planus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Skin biopsy   An incisional biopsy will be performed under local anaesthesia and tissue samples will be formalin fixed, paraffin-embedded, and sectioned for hematoxylin and eosin and immunohistochemical staining. Histological evaluation will include keratinization, acanthosis, Civatte bodies, basal cell vacuolization, pigment incontinence, and inflammatory infiltrate. Histopathological scoring will assess activity and chronicity. IHC staining will be done using the Ventana Benchmark system for CD markers. Cells will be counted on magnification in basal/suprabasal layers, and staining intensity and distribution will be comparatively analyzed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients of age 18years and above.
2. Treatment naive cases . patients who received topical treatment for 2 weeks
prior or patients on systemic therapy for 4 weeks prior
3. Patients of all gender 
 
ExclusionCriteria 
Details  1 Immunologically compromised patients and Pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Histopathological scoring of Lichen
planus . 		 Clinical severity in histopathology  
 
Secondary Outcome  
Outcome  TimePoints 

To analyze the expression of CD4 , CD8, CD1a and CD 34 . 		 To assess correlation among clinical severity , histopathology and
immunohistochemical findings in Lichen planus 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ronitalenny018@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Lichen planus (LP) is a chronic, T-cell-mediated inflammatory disorder of uncertain etiology, characterized by cytotoxic immune responses against basal keratinocytes. A novel histopathological scoring system has been proposed to objectively assess disease activity and chronicity. Langerhans cells (LCs) are thought to play a role in antigen presentation and immune activation in LP, but their exact contribution remains unclear. The interplay between CD4+ helper and CD8+ cytotoxic T cells is central to its immunopathogenesis, warranting deeper evaluation. Abnormal angiogenesis has also been implicated in sustaining chronic inflammation and lesion persistence. This study aims to correlate the clinical severity of LP with its histopathological and immunohistochemical profiles to better understand disease mechanisms and guide targeted therapy 
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